A-Spine Asia Co Ltd
⚠️ Moderate Risk
FEI: 3003986173 • Taipei • TAIWAN
FEI Number
3003986173
Location
Taipei
Country
TAIWANAddress
3f, No.298 Reiguang Road, , Taipei, , Taiwan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2011 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87HWAIMPACTOR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87HXCWRENCH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87HXPINSTRUMENT, BENDING OR CONTOURING | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87HXBPROBE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87HXXSCREWDRIVER | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87HWXTAP, BONE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87HWJAWL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87MNHORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2011 | 87MNIORTHOSIS, SPINAL PEDICLE FIXATION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is A-Spine Asia Co Ltd's FDA import refusal history?
A-Spine Asia Co Ltd (FEI: 3003986173) has 13 FDA import refusal record(s) in our database, spanning from 9/29/2011 to 9/29/2011.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. A-Spine Asia Co Ltd's FEI number is 3003986173.
What types of violations has A-Spine Asia Co Ltd received?
A-Spine Asia Co Ltd has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about A-Spine Asia Co Ltd come from?
All FDA import refusal data for A-Spine Asia Co Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.